Just when you might think recalls of heart and blood pressure drugs that began in July 2018 is "final," it seems another recall gets added. On its website, the U.S. Food & Drug Administration (FDA) continues to update this comprehensive main list of the drug category of angiotensin II receptor blockers or ARBs involved in the recall. The medications relax blood vessels, allowing them to expand.
These drug classes have been safe, first-line medications for many years: valsartan, losartan and irbesartan. Some pills are comprised of one of those products alone, while some pills are combinations of one product combined with another such as the diuretic hydrocholothiazide.
Manufacturers involved include from latest to earliest include: Torrent Pharmaceuticals Limited (several times), Prinston Pharmaceutical Inc. (Solco Healthcare, LLC), ScieGen Pharmaceuticals, Inc., Aurobindo Pharma Limited, Mylan Pharmaceuticals, Teva Pharmaceuticals, Sandoz, Inc., Camber Pharmaceuticals, Inc., and Major Pharmaceuticals.
Why the recall happened
So, you're wondering, how did this happen, and will it happen again?
The pharmaceutical companies purchased valsartan, losartan and irbesartan from overseas suppliers with factories in India and China. This saga began when laboratories discovered these drugs contained impurities N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA) had been accidentally added to some, but not all, of these drugs during manufacturing. Both are carcinogenic to humans, meaning they can cause cancer — but they may not necessarily do that.
Additionally, the FDA found fraying gaskets, rusting screws, and other problems at the Chinese facility. At the Indian plant, FDA found employees had shredded documents before an FDA inspection was to occur.
Two key points to understand: The FDA says recalls are voluntary actions taken by a company at any time to remove a defective drug product from the market. Second, as the American Heart Association (AHA) warns, please don't stop taking your medicine without contacting your doctor. "The risk of abruptly stopping blood pressure lowering drugs is significant. Your doctor will be able to find you a safe alternative."
A major health system manages the recall
If you wonder, "Is my medication on this list — or isn't it?" — you're not alone. To help simplify the core messages for you, HealthCentral spoke by phone to AHA spokesperson and cardiologist Richard C. Becker, M.D., Stonehill Professor of Medicine at the University of Cincinnati College of Medicine.
He talked first about how an institution such as his handles announcements of this magnitude, starting with referencing the FDA website for the latest updates. "We also spoke to pharmacists in our area, at the largest chains, and established a task force within our hospital system comprised of cardiologists, pharmacists, and departmental administrators," Dr. Becker says. "We wanted to think carefully about the information we had and how to best deliver the message to our patients."
The response was methodical. "The first step at our institution was to consider alternative ARBs for those on valsartan and, if not an option, then move to an ACE inhibitor," he says. "For patients with hypertension as their primary indication for medication, we also considered other drug classes and personalized care to the patient’s needs.
"We were particularly attentive to the fact that approximately one-third of our patient population is African-American, and approximately 75 percent of them historically have hypertension," he says.
Questions need answers
Patients would logically think, "I've been on this drug for years, so what does this mean for me going forward?" Dr. Becker says the following questions were likely being asked by the FDA during the recall process — and being echoed by consumers:
If a substance such as NDMA was present, how do we make sure it is known?
If it was present, what was the amount in a particular dose of medicine?
Is there a cumulative effect of this substance over time in the human body?
"In these cases, processing originated with an adulterant," says Dr. Becker. An adulterant is a chemical that can become a contaminant when added to other products.
"The FDA continued to update and tried very hard not to lump all the manufacturers into 'one basket,'" he says. He also points to the Current Good Manufacturing Practices (CGMPs), minimum requirements that ensure systems for proper design, monitoring and control of manufacturing processes and facilities. FDA acknowledges that if they work as they should, these requirements help stop occurrences of contamination, mix-ups, deviations, failures, and errors. The agency also recognizes pharmaceutical manufacturers who go beyond what's expected to exceed minimum standards.
"The FDA is developing increasingly sensitive methods for new assays — these determine the presence and amount of a substance in a drug," he says. "These recent recalls will likely lead to changes for other drug manufacturers. FDA will look at processes and make changes starting with this particular class of drugs, and then they'll look at other classes."
FDA had said in July that it's working with affected companies to reduce or eliminate the impurities from future products and to ensure there's no shortage of unaffected medications.
Quality standards differ
"Over the years, U.S. drug companies have manufactured offshore in India and China, where more flexible rules exist," says Deborah Drew, founder and member of the board of Drew Quality Group. In a phone interview with HealthCentral, she said her company is to be the first nonprofit drug manufacturing company in this country, with a mission to provide top-quality generic drugs at a rock-bottom price. Drew has a long history in large biopharma companies and a comprehensive understanding of the process of manufacturing.
An active pharmaceutical ingredient is the actual drug that delivers the therapeutic capability.
"China has been trying to take control of U.S. drug manufacturing by dumping a lot of cheap, active ingredients on the market, and of course, we (the U.S.) buy the cheapest we can find. I feel in some ways that we've lost the quality control of our drug supply."
She also says "there are major quality issues in manufacturing capacity in China and in India, and the FDA has recognized that for years. Still, for-profit drug companies are most concerned about quarterly profits and not long-term sustainability."
What you should know and do
So if 10 U.S. drug companies use the same chemical company in China, and that company doesn't maintain our quality standards — and a product becomes contaminated and is sold to a U.S. pharmaceutical manufacturer — the result is the ongoing drug recall that's taking place now, she says.
The Food and Drug Administration Safety and Innovation Act (FDASIA) of July 2012 was written to help prevent drug shortages. "It basically allows drug companies to sell contaminated products to us customers — if there's a low level of carcinogen or that contaminate can be filtered from the product prior to manufacturing here in the U.S.," says Drew. "If there's a major contaminant, FDA must issue a complete or total recall."
She presents this analogy. "When we buy a pair of sneakers and they're defective, we can see that and return them to the store. With drug products, we're buying a 'blind item,' and we consumers can have no idea what we're taking."
Not every pill from a specific manufacturer is involved when the recall is deemed "limited," she says. "It may only involve a particular lot number, which you can find out from your pharmacist."
To learn if you have a medication that's been recalled, look for the drug and manufacturer name on the bottle. For more information, call your pharmacy.
She suggests that consumers ask the pharmacist directly: "If my drug product is recalled, do you have a system to replace my product? Will you call me if my lot is on recall? Is there a replacement for it — some other product I can take safely?"
Knowledge is always power when it comes to taking care of your health.